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Also known as Risperidone Orally Disintegrating Tablets
Risperidone Orally Disintegrating · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Risperidone Orally Disintegrating | EXPERIMENTAL | Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited |
| Risperdal M-TAB | ACTIVE_COMPARATOR | (Risperdal M-TAB) 1 mg risperidone orally disintegrating tablets Janssen Pharmaceutica Products |
| Name | Type | Description |
|---|---|---|
| Risperidone Orally Disintegrating Tablets | DRUG | Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited |
Inclusion Criteria: Subjects were included in the study only if they met all of the following criteria: * Healthy non-smoking (for at least 3 months) adult male volunteers, 18-45 years of age; * Weighing at least 60 kg for males and within 15% of their ideal weights (Table of "Desirable Weights of...
Risperidone Orally Disintegrating is a small molecule formulation of risperidone that dissolves in the mouth without water. Dr. Reddy's Laboratories Ltd is developing it, and the specific therapeutic indication has not been disclosed. It is an investigational product that has been studied in Phase 1 bioavailability trials in healthy adult male volunteers.
Risperidone Orally Disintegrating targets the serotonin receptors HTR2A and HTR2C and the dopamine receptor DRD2. It acts as an antagonist at these receptors. This receptor binding profile is characteristic of risperidone-based small molecule therapeutics.
Dr. Reddy's Laboratories Ltd makes Risperidone Orally Disintegrating. The company trades under the ticker RDY. Dr. Reddy's is the sponsor of the clinical trials conducted for this orally disintegrating tablet formulation.
Risperidone Orally Disintegrating is in Phase 1 development. Two Phase 1 trials have been completed, and no trials are currently active. The program has enrolled a total of 72 participants across its completed studies.
Risperidone Orally Disintegrating has been studied in two completed Phase 1 bioavailability trials: NCT01155934, conducted under fed conditions, and NCT01155921, conducted under fasting conditions. Both trials enrolled 36 healthy adult male volunteers each and used an active-controlled, randomized design.
Yes. Risperidone Orally Disintegrating is also known as Risperidone Orally Disintegrating Tablets. Both names refer to the same Dr. Reddy's Laboratories product, a 1 mg orally disintegrating tablet formulation of risperidone evaluated in Phase 1 bioavailability studies.